FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A+MED DISPOSABLE NEEDLE
K Number: K870193
·
Decision Feb 27, 1987
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
38
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Basic Information
- Device Name
- A+MED DISPOSABLE NEEDLE
- K Number
- K870193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Can-Am Surgical Corp.
- Date Received
- January 20, 1987
- Decision Date
- February 27, 1987
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Can-Am Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K870190 | DISPOSABLE SYRINGE W/O NEEDLE | Apr 16, 1987 | Substantially Equivalent |
| K870192 | DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE | Apr 16, 1987 | Substantially Equivalent |
| K870191 | DISPOSABLE SYRINGE WITH NEEDLE | Apr 16, 1987 | Substantially Equivalent |
| K870018 | E-Z JECT INSULIN SYRINGE | Feb 4, 1987 | Substantially Equivalent |
| K870017 | AMG + MED LANCET | Jan 21, 1987 | Substantially Equivalent |